西班牙医疗器材登记法规问题集

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各国医疗器材登记法规问答集

时间：2022/10/28 drafted by Yvonne Chen

HLF-TW-10
请问西班牙对于医疗器材的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

What are the categories of medical devices in Spain? What is its official name? What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD：
在西班牙，西班牙药品和保健品局 (AEMPS)是医疗器材的监管机构。
医疗器材是指用于人体的单独或组合使用的任何仪器、装置、设备、电脑程式、材料或其他物品，用于特定诊断和/或治疗目的：
1.疾病的诊断、预防、控制、治疗或缓解
2.第二次诊断、控制、治疗、缓解或补偿伤害/缺陷
3.第三次检查、替换或修改结构解剖或生理过程
4.第四条调节受孕
应用于人体的体外检查，包括器官、血液和组织，并且不能通过药理学、免疫学或代谢方式在人体内或人体内实现其主要预期作用，但可以通过这些医疗器材辅助其功能。

产品分为I类、IIa类、IIb类、III类
•I 类：最低风险类别
不与患者接触或仅与完整皮肤接触的产品，透过身体开口（例如嘴或鼻子）进入以供临时使用的产品。
•IIa 类：中度/潜在风险
包括透过身体孔口或透过手术方式（即透过皮肤）引入人体但不打算保留在那里的产品。还有提供能量或物质的产品，或是改变生理过程的物质，只要不是以潜在危险的方式进行的。
•IIb 类：潜在高/显着风险
包括一些植入式产品、可以影响生理过程或以潜在危险方式管理物质的产品，以及用于诊断生命功能的产品。
•III 类：最高风险类别
包括一些植入式产品、旨在与中枢神经系统或中枢循环系统接触用于治疗或诊断目的的产品、含有药用物质的产品、完全吸收的产品以及含有动物衍生物的产品。

In Spain, the Spanish Agency for Medicines and Healthcare Products (AEMPS) is the regulatory agency for medical devices.
Medical device means any instrument, device, equipment, computer program, material or other article used alone or in combination with the human body for specific diagnostic and/or therapeutic purposes:

1. Diagnosis, prevention, control, treatment or alleviation of disease
2. Second diagnosis, control, treatment, mitigation or compensation of injury/deficiency
3. The third inspection, replacement or modification of structural anatomy or physiological processes
4. Article 4 Regulation of Conception
   Applied to in vitro examinations of the human body, including organs, blood and tissues, and which cannot achieve their main intended role in or within the human body through pharmacological, immunological or metabolic means, but can assist their functions through these medical devices.

Products are divided into Class I, Class IIa, Class IIb and Class III
•Class I: Lowest risk category
Products that do not come into contact with the patient or come into contact only with intact skin, products that enter through a body opening (such as the mouth or nose) for temporary use.
•Class IIa: Moderate/Potential Risk
Includes products that are introduced into the body through body orifices or surgically (i.e. through the skin) but are not intended to remain there. There are also products that provide energy or substances, or substances that alter physiological processes, as long as they are not done in a potentially dangerous way.
•Class IIb: Potentially high/significant risk
Includes some implantable products, products that can affect physiological processes or administer substances in potentially dangerous ways, and products used to diagnose vital functions.
•Class III: Highest risk category
Includes some implantable products, products intended to come into contact with the central nervous system or central circulatory system for therapeutic or diagnostic purposes, products containing medicinal substances, completely absorbed products, and products containing animal derivatives.

【参考连结】
https://www.aemps.gob.es/
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606

HLF-TW-20
外国公司要到西班牙销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什么？所需文件及申请程序为何？网页？

If a foreign company wants to sell medical devices in Spain, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
无营业特许证。
No business license.

【参考连结】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606

HLF-TW-25

HLF-TW-30
外国公司要到西班牙销售医疗器材，可以指派西班牙公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什么？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

If a foreign company wants to sell medical devices in Spain, can it assign an Spain company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以。
营业代理人需要是位于欧盟国家且是在欧盟境内营运的供应链一部分的合法公司，且必须善尽确保医疗器材符合欧盟CE标准、承担分销商的义务。
营业代理人在引进产品之前，应确保该产品具有CE标誌(如果适用)，并且製造商已在欧盟指定代表，已进行相应的合格评定并已准备好所需的技术文件。

产品安全
製造商应负起监督责任，但如果没有这样做的话，授权代表、进口商或分销商，必须在得知以下事实后立即向西班牙药品和保健品局发送通知，并告知纠正措施。
1.任何有缺陷的操作或产品特性或性能的改变，以及标籤或使用说明的任何不充分，可能导致或可能已经导致患者或健康状况严重恶化。
2.与产品特性或性能相关的任何技术或健康性质的原因，促使製造商对同类产品採取系统性措施。

Yes.
The sales agent needs to be a legal company located in an EU country and part of the supply chain operating within the EU, and must ensure that medical devices comply with EU CE standards and assume the obligations of a distributor.

Before introducing a product, the sales agent should ensure that the product has the CE mark (if applicable), and that the manufacturer has designated a representative in the EU, has conducted the corresponding conformity assessment and has prepared the required technical documents.

Product Safety
The manufacturer shall assume the responsibility for supervision, but if this is not done, the authorized representative, importer or distributor must immediately send a notification to the Spanish Agency for Medicines and Health Products upon becoming aware of the following facts and inform them of corrective measures.

1. Any defective operation or alteration in the characteristics or performance of the product, as well as any inadequacy of the labeling or instructions for use, may cause or may have caused a serious deterioration of the patient or health condition.
2. Any technical or health reasons related to the characteristics or performance of the product prompt the manufacturer to take systematic measures against similar products.

【参考连结】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
https://notificaps.aemps.es/enviotelematico/notificaps/notifica/inicio.do
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606

HLF-TW-35

HLF-TW-40
外国公司销售到西班牙医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什么文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

Do foreign companies need to apply for an approval before importing medical devices sold to Spain? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需以西班牙或欧盟成员国的公司身分于欧盟网站(EUDAMED)註册医疗器材，并于欧盟成员国中其中一个国家註册产品。

欧盟(EUDAMED)註册流程
1.角色註册(製造商/授权代表/进口商)
．公司名称/申请人名称
．联繫电话、Email
．国家、城市、街道、邮递区号等
2.UDI/设备註册
．製造商名称、地址
．风险等级
．测量功能(是/否)
．可重複用的手术器材(是/否)
．有源设备(是/否)
．辨识设备型号
．技术文件或合格证书/声明
．设备数量
．使用单位
．临床规模
．附加产品说明
．一次性使用(是/否)
．最大重複使用次数
．是否需要灭菌
．含乳胶(是/否)
．CMR/内分泌干扰物
．严重警告或禁忌
．医疗器材命名法 (CND) 代码等
3.证书和公告机构
．产品类别证书： 欧盟型式检验证书、欧盟技术文件证书、 欧盟产品验证证书。
．品质等级证书：欧盟品质管理体系证书、欧盟品质保证证书、 欧盟生产品质保证证书。
4.临床调查和性能研究(开发中)
5.警示和上市后监督(开发中)
6.市场监督(开发中)
7.欧盟颁发的许可证有效期为5年。

标籤
文件和标籤都必须用西班牙语标示，必须包含以下资料：
．製造商的名称或公司名称和地址。进口到欧盟领土并打算在其中进行分销的产品，如果製造商在欧盟内没有註册办事处，那么标籤、外包装或使用说明还必须包括授权代表的姓名、地址。
．辨识产品和包装内容物(特别是使用者)所需的资讯。
．在适当的情况下，使用无菌一词。
．批次程式码前面有批次一词或序号(视情况而定)。
．产品完全安全的日期，以年和月表示。
．关于产品为一次性使用的说明必须保持一致(如果适用)。
．若是客製化产品，须註明客製化产品。
．若是临床研究的产品，须註明仅供临床研究。
．具体储存和/或保存条件。
．特别使用说明。
．必须採取的任何警告和/或预防措施。
．灭菌方法(如果适用)。
．该产品的组成部分含有源自人体血液的物质 (如果适用)。
．如果产品的预期用途对使用者来说不明显，製造商必须在标籤和使用说明中明确说明。
．在合理可行的情况下，产品及其可分离组件必须按批次辨识，以便採取适当措施检测与产品及其可分离组件相关的可能风险。
使用说明必须酌情包含以下：
．可能的不良副作用。
．如果产品必须与其他医疗保健产品或设备安装或连接才能实现其预期目的，则必须包含有关其特性的足够资讯，以辨识要使用的正确产品或设备，以便安全使用组合。
．验证产品是否正确安装、完全安全运行的所有资料，以及必须永久性维护和校准的频率，确保产品保持良好的性能和安全性。
．有助于避免与产品实施相关的某些风险的资讯(如果适用)。
．与特定调查或治疗中产品的存在相关的相互干扰风险的资讯。
．无菌包装破损时的必要说明，以及适当的再灭菌方法(如果适用)。
．重複使用的适当程序，包括清洁、消毒、调节，以及适用时的灭菌方法(如果需要)，以及限制重複使用次数。
．如果产品在使用前必须进行灭菌，则必须制定清洁和灭菌说明。
．如果产品仅供一次性使用，则应提供已知的特性和技术因素，如果再次使用该产品可能会带来风险。
．使用产品之前必须进行的任何附加处理或操作的资讯。
．当产品发射用于医疗目的的辐射时，与所述辐射的性质、类型、强度和分佈相关的资讯。
．使用说明必须包括允许医务人员告知患者禁忌症和应採取的预防措施的资讯。

Medical devices need to be registered on the EU website (EUDAMED) as a company in Spain or an EU member state, and the product must be registered in one of the EU member states.

EU (EUDAMED) registration process

1. Role registration (manufacturer/authorized representative/importer)
   ．Company name/Applicant name
   ．Contact number, email
   ．Country, city, street, postal code, etc.
   2.UDI/Device Registration
   ．Manufacturer’s name, address
   ．Risk level
   ．Measurement function (yes/no)
   ．Reusable surgical equipment (yes/no)
   ．Active device (yes/no)
   ．Identify device model
   ．Technical documentation or certificate/declaration of conformity
   ．Equipment Quantity
   ．Use unit
   ．Clinical scale
   ．Additional product description
   ．Single use (yes/no)
   ．Maximum number of reuses
   ．Whether sterilization is required
   ．Contains latex (yes/no)
   ．CMR/endocrine disruptors
   ．SERIOUS WARNINGS OR CONTRAINDICATIONS
   ．Medical Device Nomenclature (CND) codes, etc.
2. Certificates and Notified Bodies
   ．Product category certificates: EU type inspection certificate, EU technical document certificate, EU product verification certificate.
   ．Quality grade certificate: EU Quality Management System Certificate, EU Quality Assurance Certificate, EU Production Quality Assurance Certificate.
3. Clinical investigation and performance studies (under development)
4. Warning and post-market surveillance (under development)
5. Market supervision (under development)
6. The license issued by the EU is valid for 5 years.

Label
Both documents and labels must be in Spanish and must contain the following information:
．Manufacturer’s name or company name and address. For products imported into EU territory and intended for distribution therein, if the manufacturer does not have a registered office in the EU, the label, outer packaging or instructions for use must also include the name and address of the authorized representative.
．Information needed to identify the product and package contents, especially to the user.
．Where appropriate, use the term sterile.
．The batch code is preceded by the word batch or a serial number, as appropriate.
．The date the product is completely safe, expressed in months and years.
．Instructions that the product is for single use must be consistent (if applicable).
．If it is a customized product, the customized product must be indicated.
．If it is a product for clinical research, it must be stated that it is for clinical research only.
．Specific storage and/or preservation conditions.
．Special instructions for use.
．Any warnings and/or precautions that must be taken.
．Sterilization method (if applicable).
．This product contains components derived from human blood, where applicable.
．If the intended use of a product is not obvious to the user, the manufacturer must state this clearly in the label and instructions for use.
．Where reasonably practicable, products and their separable components must be identified on a batch-by-batch basis so that appropriate measures can be taken to detect possible risks associated with the product and its separable components.
Instructions for use must include the following, where appropriate:
．Possible adverse side effects.
．If a product must be installed or connected to other healthcare products or devices to achieve its intended purpose, it must contain sufficient information about its characteristics to identify the correct product or device to be used so that the combination can be used safely.
．All information that verifies that the product is installed correctly, operates completely safely, and how frequently maintenance and calibration must be performed permanently to ensure that the product maintains good performance and safety.
．Information to help avoid certain risks associated with product implementation, if applicable.
．Information about the risk of interference associated with the presence of products under particular investigation or treatment.
．Necessary instructions in the event of damage to sterile packaging, and appropriate resterilization methods, if applicable.
．Appropriate procedures for reuse, including cleaning, disinfection, conditioning, and when applicable, sterilization methods (if required), and limiting the number of reuses.
．If a product must be sterilized before use, cleaning and sterilization instructions must be developed.
．If the product is intended for single use only, the characteristics and technical factors should be provided that are known to present risks if the product is used again.
．Information about any additional processing or operations that must be performed before using the product.
．When a product emits radiation for medical purposes, information related to the nature, type, intensity and distribution of that radiation.
．Instructions for use must include information that allows the healthcare provider to inform the patient of contraindications and precautions to be taken.

【参考连结】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606
https://ec.europa.eu/tools/eudamed/#/screen/home
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31997D0129

HLF-TW-45

HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什么文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
不行，需以西班牙或欧盟成员国的公司身分于欧盟网站(EUDAMED)註册医疗器材，并于欧盟成员国中其中一个国家註册产品。

欧盟(EUDAMED)註册流程
1.角色註册(製造商/授权代表/进口商)
．公司名称/申请人名称
．联繫电话、Email
．国家、城市、街道、邮递区号等
2.UDI/设备註册
．製造商名称、地址
．风险等级
．测量功能(是/否)
．可重複用的手术器材(是/否)
．有源设备(是/否)
．辨识设备型号
．技术文件或合格证书/声明
．设备数量
．使用单位
．临床规模
．附加产品说明
．一次性使用(是/否)
．最大重複使用次数
．是否需要灭菌
．含乳胶(是/否)
．CMR/内分泌干扰物
．严重警告或禁忌
．医疗器材命名法 (CND) 代码等
3.证书和公告机构
．产品类别证书： 欧盟型式检验证书、欧盟技术文件证书、 欧盟产品验证证书。
．品质等级证书：欧盟品质管理体系证书、欧盟品质保证证书、 欧盟生产品质保证证书。
4.临床调查和性能研究(开发中)
5.警示和上市后监督(开发中)
6.市场监督(开发中)
7.欧盟颁发的许可证有效期为5年。

标籤
文件和标籤都必须用西班牙语标示，必须包含以下资料：
．製造商的名称或公司名称和地址。进口到欧盟领土并打算在其中进行分销的产品，如果製造商在欧盟内没有註册办事处，那么标籤、外包装或使用说明还必须包括授权代表的姓名、地址。
．辨识产品和包装内容物(特别是使用者)所需的资讯。
．在适当的情况下，使用无菌一词。
．批次程式码前面有批次一词或序号(视情况而定)。
．产品完全安全的日期，以年和月表示。
．关于产品为一次性使用的说明必须保持一致(如果适用)。
．若是客製化产品，须註明客製化产品。
．若是临床研究的产品，须註明仅供临床研究。
．具体储存和/或保存条件。
．特别使用说明。
．必须採取的任何警告和/或预防措施。
．灭菌方法(如果适用)。
．该产品的组成部分含有源自人体血液的物质 (如果适用)。
．如果产品的预期用途对使用者来说不明显，製造商必须在标籤和使用说明中明确说明。
．在合理可行的情况下，产品及其可分离组件必须按批次辨识，以便採取适当措施检测与产品及其可分离组件相关的可能风险。
使用说明必须酌情包含以下：
．可能的不良副作用。
．如果产品必须与其他医疗保健产品或设备安装或连接才能实现其预期目的，则必须包含有关其特性的足够资讯，以辨识要使用的正确产品或设备，以便安全使用组合。
．验证产品是否正确安装、完全安全运行的所有资料，以及必须永久性维护和校准的频率，确保产品保持良好的性能和安全性。
．有助于避免与产品实施相关的某些风险的资讯(如果适用)。
．与特定调查或治疗中产品的存在相关的相互干扰风险的资讯。
．无菌包装破损时的必要说明，以及适当的再灭菌方法(如果适用)。
．重複使用的适当程序，包括清洁、消毒、调节，以及适用时的灭菌方法(如果需要)，以及限制重複使用次数。
．如果产品在使用前必须进行灭菌，则必须制定清洁和灭菌说明。
．如果产品仅供一次性使用，则应提供已知的特性和技术因素，如果再次使用该产品可能会带来风险。
．使用产品之前必须进行的任何附加处理或操作的资讯。
．当产品发射用于医疗目的的辐射时，与所述辐射的性质、类型、强度和分佈相关的资讯。
．使用说明必须包括允许医务人员告知患者禁忌症和应採取的预防措施的资讯。

No, you need to register the medical device on the EU website (EUDAMED) as a company in Spain or an EU member state, and register the product in one of the EU member states.

EU (EUDAMED) registration process

1. Role registration (manufacturer/authorized representative/importer)
   ．Company name/Applicant name
   ．Contact number, email
   ．Country, city, street, postal code, etc.
   2.UDI/Device Registration
   ．Manufacturer’s name, address
   ．Risk level
   ．Measurement function (yes/no)
   ．Reusable surgical equipment (yes/no)
   ．Active device (yes/no)
   ．Identify device model
   ．Technical documentation or certificate/declaration of conformity
   ．Equipment Quantity
   ．Use unit
   ．Clinical scale
   ．Additional product description
   ．Single use (yes/no)
   ．Maximum number of reuses
   ．Whether sterilization is required
   ．Contains latex (yes/no)
   ．CMR/endocrine disruptors
   ．SERIOUS WARNINGS OR CONTRAINDICATIONS
   ．Medical Device Nomenclature (CND) codes, etc.
2. Certificates and Notified Bodies
   ．Product category certificates: EU type inspection certificate, EU technical document certificate, EU product verification certificate.
   ．Quality grade certificate: EU Quality Management System Certificate, EU Quality Assurance Certificate, EU Production Quality Assurance Certificate.
   4.Clinical investigation and performance studies (under development)
3. Warning and post-market surveillance (under development)
4. Market supervision (under development)
5. The license issued by the EU is valid for 5 years.

Label
Both documents and labels must be in Spanish and must contain the following information:
．Manufacturer’s name or company name and address. For products imported into EU territory and intended for distribution therein, if the manufacturer does not have a registered office in the EU, the label, outer packaging or instructions for use must also include the name and address of the authorized representative.
．Information needed to identify the product and package contents, especially to the user.
．Where appropriate, use the term sterile.
．The batch code is preceded by the word batch or a serial number, as appropriate.
．The date the product is completely safe, expressed in months and years.
．Instructions that the product is for single use must be consistent (if applicable).
．If it is a customized product, the customized product must be indicated.
．If it is a product for clinical research, it must be stated that it is for clinical research only.
．Specific storage and/or preservation conditions.
．Special instructions for use.
．Any warnings and/or precautions that must be taken.
．Sterilization method (if applicable).
．This product contains components derived from human blood, where applicable.
．If the intended use of a product is not obvious to the user, the manufacturer must state this clearly in the label and instructions for use.
．Where reasonably practicable, products and their separable components must be identified on a batch-by-batch basis so that appropriate measures can be taken to detect possible risks associated with the product and its separable components.
Instructions for use must include the following, where appropriate:
．Possible adverse side effects.
．If a product must be installed or connected to other healthcare products or devices to achieve its intended purpose, it must contain sufficient information about its characteristics to identify the correct product or device to be used so that the combination can be used safely.
．All information that verifies that the product is installed correctly, operates completely safely, and how frequently maintenance and calibration must be performed permanently to ensure that the product maintains good performance and safety.
．Information to help avoid certain risks associated with product implementation, if applicable.
．Information about the risk of interference associated with the presence of products under particular investigation or treatment.
．Necessary instructions in the event of damage to sterile packaging, and appropriate resterilization methods, if applicable.
．Appropriate procedures for reuse, including cleaning, disinfection, conditioning, and when applicable, sterilization methods (if required), and limiting the number of reuses.
．If a product must be sterilized before use, cleaning and sterilization instructions must be developed.
．If the product is intended for single use only, the characteristics and technical factors should be provided that are known to present risks if the product is used again.
．Information about any additional processing or operations that must be performed before using the product.
．When a product emits radiation for medical purposes, information related to the nature, type, intensity and distribution of that radiation.
．Instructions for use must include information that allows the healthcare provider to inform the patient of contraindications and precautions to be taken.

【参考连结】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606
https://ec.europa.eu/tools/eudamed/#/screen/home
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31997D0129

HLF-TW-55

HLF-TW-60
经过核准登记的医疗器材，进口到西班牙要检附什么文件？经过什么手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

What documents are required when importing approved medical devices into Spain? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
进口许可证
从第三国进口医疗器材和产品，需取得西班牙药品和医疗器材局(AEMPS) 颁发的进口许可证。
1.申请人：自然人或法人
2.申请网页：https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html
3.进口许可证期限：3到6个月
4.文件
．技术报告：说明如何在设施、流程和认证等方面遵守现行法规。
．拥有 AEMPS 批准的内部或外包仓储，仓库的大小将取决于公司的活动和所涉及的产品类型。
．具备一名合格人员，除其他职责外，负责批次放行和分发。未经合格人员授权，公司不得销售进口产品。

海关

1. 经济经营者註册和识别(EORI)
   向西班牙海关( OEA )申请取得 EORI 号码
   网页：https://sede.agenciatributaria.gob.es/Sede/inicio.html
   申请书内容
   ．自然人：护照或其他有效身分证件；公司名称/责任人姓名
   ．西班牙的纳税住所。
   ．创建日期/生日
   ．人员类型：自然人/法人/团体
   ．地址、电话、电子邮件
   ．联络资讯、联络人姓名、地址、电话号码、传真号码、电子邮件
   ．商业登记证明
   ．如果申请人不是自然人，也不是被授予EORI代码的法人或团体的法定代表人则必须缴交：经公证的授权书正本、授权书原件
   ．经济活动部门4位代码：商业登记处註明的欧盟经济活动统计分类(NACE)主要经济活动的4位数代码
2. 报关
   申报单内容
   ．运营商的名称和EORI
   ．清关办事处代码
   ．报关处代码
   ．包裹数量
   ．发件人的姓名和地址、收件人的姓名和地址
   ．商品的商业描述
   ．以千克为单位的总质量
   ．原产国代码
   ．发票价值和货币
   ．进口声明等
   单一行政文件 (SAD)
   ．託运人
   ．收件人
   ．申报人
   ．出发时运输工具、国家
   ．过境运输工具、国家
   ．运输方式
   ．商业编号
   ．付款方式
   ．目的地代码
   ．交货条款
   ．交易性质
   ．货柜编号、密封贴及编号
   ．商品代码、重量
   ．税务计算
   ．抵港日期
   ．办事处
   ．声明人等
3. 清关所需文件
   ．商业发票副本 (西班牙语)
   ．原产地声明

行销通知
1.任何自然人或法人首次在西班牙境内提供 IIa、IIb 或 III 类产品供分销和/或使用时，应向西班牙药品和保健品管理局联繫。
2.网页：
https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html
3.通知内容
．自然人/法人的身分资料
．产品所属类别
．产品在西班牙的商业名称以及产品在欧盟销售的商业名称(如果与第一个名称不同)
．产品类别、类型和型号
．产品的描述和预期用途
．製造商、製造地点及其授权代表的资料(如果适用)
．CE 标誌、应用附件和 CE 合格证书副本的评定指定机构辨识号码
．公告机构认证的标籤和使用说明
．产品将在西班牙销售的标籤和使用说明(西班牙语)
．在西班牙上市或投入使用的日期
．西班牙经销商的身份资料

Importing medical equipment and products from third countries requires an import license issued by the Spanish Agency for Medicines and Medical Devices (AEMPS).

1. Applicant: natural person or legal person
2. Application webpage: https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html
3. Import license period: 3 to 6 months
4. Documents
   ．Technical Report: Describes how to comply with current regulations in terms of facilities, processes and certifications.
   ．With AEMPS approved in-house or outsourced warehousing, the size of the warehouse will depend on the company’s activities and the types of products involved.
   ．Have a qualified person responsible for batch release and distribution, among other duties. Companies are not allowed to sell imported products without authorization from qualified personnel.

Customs

1. Economic Operator Registration and Identification (EORI)
   Apply to Spanish Customs (OEA) to obtain an EORI number
   URL: https://sede.agenciatributaria.gob.es/Sede/inicio.html
   Application content
   ．Natural person: passport or other valid identity document; company name/name of responsible person
   ．Spanish tax residence.
   ．Creation date/birthday
   ．Personnel type: natural person/legal person/group
   ．Address, phone number, email
   ．Contact information, contact name, address, telephone number, fax number, email
   ．Business registration certificate
   ．If the applicant is not a natural person, nor is he the legal representative of a legal person or group that has been granted an EORI code, he must submit: the original notarized power of attorney, and the original power of attorney.
   ．4-digit code of the economic activity sector: the 4-digit code of the main economic activity in the Statistical Classification of Economic Activity in the European Union (NACE) indicated in the commercial register
2. Customs declaration
   Declaration form content
   ．Operator’s name and EORI
   ．Customs clearance office code
   ．Customs declaration office code
   ．Package quantity
   ．Sender’s name and address, Recipient’s name and address
   ．Commercial description of the product
   ．Total mass in kilograms
   ．Country of origin code
   ．Invoice value and currency
   ．Import declaration, etc.
   Single Administrative Document (SAD)
   ．Shipper
   ．Recipient
   ．Notifier
   ．Means of transportation and country at departure
   ．Transit transport, country
   ．Transportation method
   ．Business number
   ．Payment method
   ．Destination code
   ．Terms of Delivery
   ．Nature of transaction
   ．Container number, sealing sticker and serial number
   ．Product code, weight
   ．Tax calculation
   ．Arrival date
   ．Office
   ．Declarant etc.
3. Documents required for customs clearance
   ．Copy of commercial invoice (Spanish)
   ．Declaration of origin

Marketing Notice

1. Any natural or legal person offering for the first time a product of category IIa, IIb or III for distribution and/or use in Spain should contact the Spanish Agency for Medicines and Health Products.
   2.URL:
   https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html
   3.Notification content
   ．Identity data of natural/legal persons
   ．Product category
   ．The commercial name of the product in Spain and the commercial name of the product sold in the EU (if different from the first name)
   ．Product categories, types and models
   ．Product description and intended use
   ．Information about the manufacturer, manufacturing location and its authorized representative (if applicable)
   ．Identification number of the notified body for CE marking, application accessories and copy of CE certificate of conformity
   ．Notified body certified labels and instructions for use
   ．Labels and instructions for use (Spanish) for products to be sold in Spain
   ．Date of launch or entry into service in Spain
   ．Spanish dealer’s identity information

【参考连结】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606
https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html

HLF-TW-70
西班牙医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
CE认证

1. CE验证是製造商或其授权代表确保并声明产品符合CE型式检验规定。
2. 製造程序保证产品符合 CE 型式检验证书中所述的类型以及适用法令要求，且在开始製造之前，必须准备製造程序文件。
   3.对于无菌产品要确定无菌条件及其製造维护。
   4.製造商应承诺建立并维持最新的系统程序。
   5.所有产品应单独检验，并应进行标准中定义的适当测试或同等测试，以验证其符合检验证书中描述的类型（如适用）
   6.公告机构应在每个核准的产品上放置或安排其编号，并颁发与所进行的测试相对应的书面合格证书。
   7.製造商将以同质批次的形式展示製造的产品。
   8.从每批产品中随机抽取样本、单独检查。
   9.产品的统计控制将透过属性和/或变数进行。
   10.製造商或其授权代表必须向国家当局提供该产品至少 5 年的期限，如果是可植入产品，则在最后一个产品製造完成后至少 15 年。

符合性声明
1.适用于 IIa 类产品。
2.製造商应透过合格声明确保并声明 IIa 类产品是按照技术文件製造的，并符合要求法令。
3.机构进行的验证将以 IIa 类产品与技术文件的符合性为目标。

CE certification

1. CE verification is when the manufacturer or its authorized representative ensures and declares that the product complies with CE type inspection regulations.
2. The manufacturing process ensures that the product conforms to the type described in the CE type examination certificate and applicable statutory requirements, and before starting manufacturing, manufacturing process documentation must be prepared.
3. For sterile products, the sterile conditions and manufacturing maintenance must be determined.
4. The manufacturer should commit to establishing and maintaining the latest system procedures.
5. All products shall be individually inspected and shall be subjected to appropriate tests defined in the standard or equivalent tests to verify that they conform to the type described in the inspection certificate (if applicable)
6. The notified body shall place or arrange its number on each approved product and issue a written certificate of conformity corresponding to the tests performed.
7. Manufacturers will display manufactured products in homogeneous batches.
8. Randomly select samples from each batch of products and inspect them individually.
9. Statistical control of the product will be carried out through attributes and/or variables.
10. The manufacturer or his authorized representative must make the product available to the national authorities for a period of at least 5 years, or in the case of implantable products, at least 15 years after the last product was manufactured.

Declaration of conformity

1. Applicable to Class IIa products.
2. The manufacturer should ensure and declare through a declaration of conformity that Class IIa products are manufactured in accordance with technical documents and comply with required regulations.
3. The verification conducted by the agency will target the conformity of Class IIa products with technical documentation.

【参考连结】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606

HLF-TW-75

HLF-TW-77

HLF-TW-80
外国子公司进口医疗器材后，如果委託西班牙的经销商销售，经销商需要医疗器材营业许可证吗？假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

After a foreign subsidiary imports medical devices and entrusts a distributor in Spain to sell it, does the distributor need a medical devices business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
无营业许可证。

产品安全
製造商应负起监督责任，但如果没有这样做的话，授权代表、进口商或分销商，必须在得知以下事实后立即向西班牙药品和保健品局发送通知，并告知纠正措施。
1.任何有缺陷的操作或产品特性或性能的改变，以及标籤或使用说明的任何不充分，可能导致或可能已经导致患者或健康状况严重恶化。
2.与产品特性或性能相关的任何技术或健康性质的原因，促使製造商对同类产品採取系统性措施。

No business license.
Product Safety
The manufacturer shall assume the responsibility for supervision, but if this is not done, the authorized representative, importer or distributor must immediately send a notification to the Spanish Agency for Medicines and Health Products upon becoming aware of the following facts and inform them of corrective measures.

1. Any defective operation or alteration in the characteristics or performance of the product, as well as any inadequacy of the labeling or instructions for use, may cause or may have caused a serious deterioration of the patient or health condition.
2. Any technical or health reasons related to the characteristics or performance of the product prompt the manufacturer to take systematic measures against similar products.

【参考连结】
https://notificaps.aemps.es/enviotelematico/notificaps/notifica/inicio.do

HLF-TW-85

各国医疗器材登记法规问答集

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